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510(k) Data Aggregation

    K Number
    K202542
    Device Name
    Allura Vaginal Stent
    Manufacturer
    PMT Corporation
    Date Cleared
    2020-09-30

    (28 days)

    Product Code
    KXP
    Regulation Number
    884.3900
    Why did this record match?
    Applicant Name (Manufacturer) :

    PMT Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Allura™ Vaginal Stent is indicated to maintain the vaginal canal following radiological treatment or surgical procedures to restore, enlarge or create a vagina.
    Device Description
    Not Found
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    K Number
    K151790
    Device Name
    PMT Platinum Depthalon Depth Electrode
    Manufacturer
    PMT CORPORATION
    Date Cleared
    2016-07-14

    (379 days)

    Product Code
    GZL
    Regulation Number
    882.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    PMT CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Platinum Depthalon® Depth Electrodes are intended for temporary (<30 day) use with recording, monitoring, and stimulation equipment for the recording, monitoring and stimulation of electrical signals in the subsurface of the brain.
    Device Description
    Not Found
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